NCT02924350

The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH)

A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This single center study will investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving DH compared with a standard fluoride dentifrice after short term use.

Detailed description

This was a single centre, 3 day, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study in participants with at least two sensitive teeth that met the study criteria at the Screening and Baseline visits. Study participants were in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening. Participants were assessed at Baseline (pre-treatment), immediately after first treatment, and after 3 days twice daily treatment, to monitor clinical efficacy and safety. At the Screening visit, participants gave their written informed consent to participate in the study. Demography, medical history and concomitant medications were recorded, followed by an oral examination which included an oral soft tissue (OST) examination and assessments to determine eligible teeth. Eligible participants were supplied with a regular fluoride dentifrice (containing 1450 parts per million (ppm) fluoride as sodium monofluorophosphate) to use twice daily (morning and evening) during the acclimatisation period (4-8 weeks) between Screening and Baseline. Each brushing occasion was recorded in a product use diary. First use of the acclimatisation dentifrice was carried out under supervision at the study site. At Baseline (Day 0, pre-treatment), eligibility to continue was assessed. Following an OST examination, tooth sensitivity was assessed (first to a tactile stimulus \[Yeaple probe, maximum 20 grams (g) pressure\], and then to an evaporative air stimulus \[Schiff sensitivity scale\]), and the inclusion/exclusion criteria were reviewed. Eligible participants were stratified and randomised to treatment. First use of allocated study treatment was by direct application to the 2 selected test teeth, and was carried out under supervision at the study site. The sensitivity of the 2 test teeth was reassessed immediately post-treatment, first to a tactile stimulus (Yeaple probe, maximum 80g pressure), and then to an evaporative air stimulus (Schiff sensitivity scale). Participants completed a supervised whole mouth brushing with their allocated study treatment prior to leaving the study site. Sensitivity was re-assessed after 3 days twice daily treatment. Each use of study treatment was recorded in a product use diary. Adverse events (AEs) were documented from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product. Incidents were documented from completion of the first use of investigational product until 5 days following last administration of study product.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
OTHER	Stannous fluoride	Supervised direct application (Day 0): Participants applied a pea-sized dose of test dentifrice to each of the 2 qualifying test teeth using their washed and clean finger to gently rub the dentifrice into the tooth's cervical margin for 60 sec. No rinsing was permitted after treatment. Supervised brushing (Day 0, before leaving the site) and Home use (3 days): after dosing a dry toothbrush with a full strip of dentifrice, participants brushed each of the 2 qualifying test teeth first, followed by their whole mouth for at least 60 sec. Participants were permitted to rinse with 5 mL tap water (room temperature) for 5 sec. maximum after brushing on supervised brushing (Day 0) and were also permitted to rinse with tap water after brushing on home use (3 days).
OTHER	Sodium monofluorophosphate	Supervised direct application (Day 0): participants applied a pea-sized dose of control dentifrice to each of the 2 qualifying test teeth using their washed and clean finger to gently rub the dentifrice into the tooth's cervical margin for 60 sec. No rinsing was permitted after treatment. Supervised brushing (Day 0, before leaving the site) and home use (3 days): after dosing a dry toothbrush with a full strip of dentifrice, participants brushed their whole mouth thoroughly for at least 60 sec. Participants were permitted to rinse with 5mL tap water (room temperature) for 5 sec. maximum after brushing in supervised brushing on Day 0 and were also permitted to rinse with tap water after brushing on home use (3 days).

Timeline

• Start date: 2016-11-07
• Primary completion: 2017-03-17
• Completion: 2017-03-17
• First posted: 2016-10-05
• Last updated: 2018-08-20
• Results posted: 2018-08-20

Locations

1 site across 1 country: United Kingdom